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510(k) Data Aggregation

    K Number
    K991380
    Device Name
    OIL FOR TISSUE CULTURE
    Manufacturer
    ADVANCED REPRODUCTIVE TECHNOLOGIES
    Date Cleared
    2000-04-19

    (364 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED REPRODUCTIVE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Oil for Tissue Culture is used in covering tissue culture in in-vitro fertilization, embryo culture and micromanipulative procedures such as ICSI and assisted hatching.
    Device Description
    Not Found
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    K Number
    K991395
    Device Name
    QUINN'S HTF MEDIUM, QUINN'S HTF MEDIUM WITH HEPES, QUINN'S BASAL XI HTF MEDIUM, QUINN'S D3+ HTF MEDIUM
    Manufacturer
    ADVANCED REPRODUCTIVE TECHNOLOGIES
    Date Cleared
    2000-02-15

    (300 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED REPRODUCTIVE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Media for Embryo Preparation products that are used for assisted reproduction procedures. These media come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage. Quinn's® HTF Medium was developed for in vitro fertilization and procedures involving the culture of early cleavage stage mammalian embryos. Quinn's® HTF Medium with HEPES was developed for in vitro procedures involving manipulations of gametes and embryos not requiring the use of a CO2 incubator. Such procedures include oocyte recovery, gamete washing, micromanipulation, embryo transfer and cryopreservation. Quinn's® Basal XI HTF Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos from Day 1 through to Day 3. Quinn's® D3+ Medium was developed for in vitro procedures involving the culture of early cleavage stage mammalian embryos. This is the medium for culture of embryos after Day 3 of development.
    Device Description
    Media for Embryo Preparation products that are used for assisted reproduction procedures. These media come in direct physical contact with human gametes or embryos for the purposes of preparation, maintenance, transfer or storage.
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    K Number
    K991392
    Device Name
    HUMAN SERUM ALBUMIN
    Manufacturer
    ADVANCED REPRODUCTIVE TECHNOLOGIES
    Date Cleared
    2000-02-07

    (292 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED REPRODUCTIVE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Human Serum Albumin is a macromolecular supplement used in media for IVF, ART, GIFT, ICSI, embryo culture, embryo transfer, cryopreservation and sperm washing for IUI.
    Device Description
    Not Found
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    K Number
    K991379
    Device Name
    QUINN'S SPERM WASHING MEDIUM
    Manufacturer
    ADVANCED REPRODUCTIVE TECHNOLOGIES
    Date Cleared
    2000-02-02

    (287 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED REPRODUCTIVE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quinn's® Sperm Washing Medium is for in vitro procedures involving sperm washing and incubation.
    Device Description
    Quinn's® Sperm Washing Medium
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    K Number
    K991391
    Device Name
    PVP, POLYVINYLPYRROLIDONE 10% (W/V) IN HEPES-HTF
    Manufacturer
    ADVANCED REPRODUCTIVE TECHNOLOGIES
    Date Cleared
    2000-01-10

    (264 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED REPRODUCTIVE TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PVP is used for the intracytoplasmic sperm injection (ICSI) procedure to decrease the motility of spermatozoa, prevent their sticking to the injection pipette during the procedure and to give more control over the flow of fluid in the ICSI needle.
    Device Description
    PVP, 10%, (W/V) in Hepes-HTF (Tissue Culture Media)
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